Quality Assurance

Quality is our first priority at Starwest. To support our customers’ expectations for high quality products, we continue to expand and advance our quality control laboratory and processes. With our sophisticated, high-tech laboratory equipment and experienced Quality Assurance team, Starwest has made a commitment to continued excellence in product quality. We believe that quality begins with the knowledge and experience of our raw material suppliers from around the world, and continues through the shipment of product to our customers.

In-House Quality Control Laboratory

Starwest maintains a modern, in-house laboratory staffed by experienced professionals. We provide complete product analyses, quickly and efficiently, with validated analytical procedures and state-of-the-art equipment. Specification Sheets, Certificates of Analysis, Material Safety Data Sheets, and Product Flow Charts are provided for each of our products.

Our Quality Assurance team includes individuals dedicated to equipment and process validation, document control, training, and maintenance. FDA-compliant manufacturing protocols are followed, and our products meet these requirements for identity, strength,
quality and purity.

Our validated quality assurance testing includes:

• Organoleptic testing to ensure proper appearance, color, aroma and flavor.
• Microscopic and macroscopic inspection for foreign matter.
• HPTLC for identification, and to verify purity and authenticity.
• ICP-MS for heavy metal analysis.
• Microbiology testing for pathogens such as E. coli and salmonella.
• Chemical analyses for moisture content, volatile oil, ash, and acid insoluble ash.

High Performance Thin Layer Chromatography (HPTLC)

In compliance with cGMPs, Starwest uses HPTLC testing, which is an essential tool to accurately determine product identity and purity. By quantifying or comparing the distribution patterns of marker compounds in different solvent systems (unique to each plant and class of actives) against our proprietary Botanical Reference library, our laboratory personnel can verify product identity and identify known adulterates.

Inductively Coupled Plasma- Mass Spectrometry (ICP-MS)

Inductively Coupled Plasma- Mass Spectrometry is used to measure trace metals in a variety of solutions. ICP-MS offers a very sensitive, specific and reproducible way to determine heavy metal concentration. It can identify and quantify each metallic impurity with high sensitivity; and, can be used to test for the entire Periodic Table in one analysis. ICP detection limits for most elements are in the part-per-billion (ppb) range.

cGMP Compliant

Starwest complies with current Good Manufacturing Practices, with protocols firmly in place for documentation, validation, and qualification systems to ensure compliance with the FDA and other regulatory bodies. We thoroughly document every aspect of the procedures and operations involved, including receiving, processing, packaging, and shipping.

We have designed a full allergen prevention program, and have implemented tight controls in our manufacturing processes to prevent cross-contamination of our products with allergens.